PBAC's latest decision on Esketamine: Recommended with restriction (2024). Considered for Treatment of treatment-resistant depression (major depressive disorder) in adults who have not responded adequately to at least two separate courses of treatment with different antidepressants, each of adequate dose and duration, in the current moderate to severe depressive episode.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
4
first 2021
Submissions
4
2021 → 2024
Eligible population
Adults aged 18 years or older with major depressive disorder who have not responded adequately to at least two separate courses of treatment with different antidepressants (from different pharmacological classes) of adequate dose and duration in the current moderate to severe depressive episode, treated in conjunction with a newly initiated (or concomitant) oral antidepressant under supervision of a healthcare professional.
Therapy area
Mental health
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
Other
Comparator
newly initiated oral antidepressant
Economic model
CUA
ICER note
ICER values are redacted/commercially sensitive; the document does not publish numeric ICER figures
Risk sharing
Risk-sharing arrangement in place — Risk-sharing arrangement with a higher rebate percentage for any use above the subsidisation caps
Submission history
Jul 2021: Not recommended · Authority Required
Jul 2022: Recommended with restriction · Authority Required
Jul 2023: Recommended with restriction · Authority Required
Jul 2024: Recommended with restriction · Authority Required